Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary)
AstraZeneca
294 participants
Apr 24, 2023
INTERVENTIONAL
Conditions
Summary
GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.
Eligibility
Inclusion Criteria7
- Age ≥18 years at the time of signing the ICF.
- Provision of a signed and dated written ICF.
- Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.
- Adequate organ and bone marrow function.
- At least 1 measurable not previously irradiated lesion per RECIST 1.1
- Life expectancy of at least 12 weeks at the time of screening.
- Willing and able to provide an adequate tumor sample.
Exclusion Criteria8
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness.
- History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.
- Active infection, brain metastases or spinal cord compression.
- Participants co-infected with HBV and hepatitis D virus (HDV).
- Previous treatment in the present study.
- For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.
Interventions
CTLA-4/Anti-PD-1 Bispecific Antibody
15 mg/kg, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
Daily use per oral (8 mg capsules/day for participants \< 60 kg or 12 mg/day for participants ≥ 60 kg) of 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
anti- PD-1 and TIGIT bispecific antibody
1000 mg/m2, IV infusion
25 mg/m2, IV infusion
Locations(60)
View Full Details on ClinicalTrials.gov
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NCT05775159